The ‘Healthy Dads, Healthy Kids’ randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children

Abstract Background As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. Methods A randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m2), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6 months (time 3) and 9 months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of the intervention, mixed between-within 3 (conditions) × 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups. Discussion This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle. Trial registration ClinicalTrials.govNCT04474509. Registered on July 4, 2020

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Uncovering the Truth

American Journal of Lifestyle Medicine ◽

10.1177/1559827617737938 ◽

2017 ◽

Vol 12 (1) ◽

pp. 49-50

Author(s):

George E. Guthrie

Keyword(s):

Randomized Controlled Trial ◽

Basic Science ◽

Healthy Lifestyle ◽

Controlled Trial ◽

Lifestyle Changes ◽

Level Of Evidence ◽

Lifestyle Medicine ◽

Randomized Controlled ◽

Standards Of Practice ◽

Guidelines And Standards

Finding the truth is important. In the field of lifestyle medicine the randomized controlled trial has significant limitations. Physicians and patients need to know the truth about the healthy lifestyle changes and their ability to prevent and reverse disease. To meet this challenge, the American College of Lifestyle Medicine has established a committee of experts (HEaLM), under the leadership of David Katz to create a level of evidence construct for ranking lifestyle medicine evidence that includes evidence from basic science and epidemiologic trials. This tool will be used by the new Expert Lifestyle Medicine Panel to create guidelines and standards of practice.

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Development of a Healthy Lifestyle Module to Improve Mental Health in Adolescent Students: Protocol of a Randomized Controlled Trial

Biomedical Journal of Scientific & Technical Research ◽

10.26717/bjstr.2021.36.005787 ◽

2021 ◽

Vol 36 (1) ◽

Author(s):

Esra Tajik

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Healthy Lifestyle ◽

Controlled Trial ◽

Adolescent Students ◽

Randomized Controlled

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Abstract MP33: The Deaf Weight Wise Study: A Unique Clinical Trial of Health Behavior Modification with Deaf Adults

Circulation ◽

10.1161/circ.129.suppl_1.mp33 ◽

2014 ◽

Vol 129 (suppl_1) ◽

Author(s):

Steven Barnett ◽

Erika Sutter ◽

Thomas Pearson ◽

Keyword(s):

Public Health ◽

Repeated Measures ◽

Lifestyle Modification ◽

Healthy Lifestyle ◽

Controlled Trial ◽

Intervention Group ◽

Lifestyle Program ◽

Deaf Adults ◽

Delayed Group ◽

Healthy Lifestyle Program

Introduction: Deaf people who use American Sign Language (ASL) comprise linguistic and cultural minority populations without access to language-concordant health information and healthcare. Deaf ASL users are rarely included in health research or public health surveillance. Recent research with Deaf ASL users found a higher prevalence of obesity than in the general population. No randomized trials of lifestyle modification or weight reduction have ever been attempted with Deaf ASL users. Methods: We worked with the Rochester (NY) Deaf community to adapt a 16-week healthy lifestyle program previously shown to be effective with hearing people. We adapted the curriculum and research measures to be culturally and linguistically appropriate. We used a group intervention format recommended by our Deaf partners, and trained group leaders who were Deaf, ASL fluent and had backgrounds in counseling, public health, or healthcare. For this Deaf Weight Wise (DWW) trial, we recruited Deaf adults aged 40-70 with a BMI of 25-45 from community settings, and randomized participants to immediate intervention or intervention delayed 1 year. We will collect data from DWW trial participants over two years. We present analyses of data after 6 months here. Primary outcomes were changes in weight, BMI and scores on two standard measures: Dietary Risk Assessment (DRA) and Physical Activity Assessment (PAA). We used group by time repeated measures ANOVA to examine changes from baseline to 6 months for the immediate group and delayed group (no intervention yet). Hypothesis: The immediate intervention group would have greater reduction in weight and BMI as well as improvement in DRA and PAA scores six months after baseline compared with the delayed intervention group. Results: At baseline, the 104 participants’ mean age was 53.5 years; 68.3% (71 of 104) were female and 91.3% (95/104) were White. Randomization was successful based on baseline data. At 6 months, the immediate group weight changed -3.35kg (1.0 s.e.; p=.002) and BMI changed -1.35 (0.4 s.e.; p≤.0001) compared with the delayed group. Most of the immediate group (58.3%, 28/48) lost ≥ 5% of baseline weight versus 14.3% (8/56) of the delayed group (p≤.0001). Changes in mean DRA (p=.055) and moderate PAA (p=.054) scores numerically favored the immediate group. Conclusions: Deaf Weight Wise is the first randomized controlled trial of a healthy lifestyle program with Deaf ASL users. This culturally appropriate and language accessible behavioral intervention was feasible and highly effective with this underserved and rarely studied population.

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